Form 8-K

8-K — Ocugen, Inc.

Accession: 0001104659-26-105968

Filed: 2026-09-08

Period: 2026-09-01

CIK: 0001372299

SIC: 2836 (BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES))

Item: Regulation FD Disclosure

Item: Other Events

Item: Financial Statements and Exhibits

Documents

8-K — tm2624985d1_8k.htm (Primary)

EX-99.1 — EXHIBIT 99.1 (tm2624985d1_ex99-1.htm)

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8-K — FORM 8-K

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0001372299

2026-09-01

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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d)

of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported):

September 1, 2026

OCUGEN, INC.

(Exact name of registrant as specified in its charter)

Delaware

001-36751

04-3522315

(State or other jurisdiction

of incorporation)

(Commission File

Number)

(IRS Employer

Identification No.)

11 Great Valley Parkway

Malvern, Pennsylvania

19355

(Address of principal executive offices)

(Zip Code)

Registrant’s telephone number, including

area code: (484) 328-4701

N/A

(Former name or former address, if changed since

last report.)

Check the appropriate box below if the Form 8-K filing is intended

to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction

A.2. below):

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of each class

Trading

Symbol(s)

Name of each exchange

on which registered

Common Stock, par value $0.01 per share

OCGN

The Nasdaq Stock Market LLC

(The Nasdaq Capital Market)

Indicate by check mark whether the registrant is an emerging growth

company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange

Act of 1934 (§ 240.12b-2 of this chapter).

Emerging growth company ¨

an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying

with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ¨

Item 7.01 Regulation FD Disclosure.

Attached as Exhibit 99.1 and incorporated herein

by reference is a presentation that Ocugen, Inc. (the “Company” or “Ocugen”) will post on its website on September

8, 2026 and may use from time to time in presentations or discussions with investors, analysts, and other parties.

The information disclosed under Item 7.01 of this

Current Report on Form 8-K (the “Report”), including Exhibit 99.1, is being furnished and shall not be deemed “filed”

for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the "Exchange Act"), or otherwise subject to

the liabilities of that section, and shall not be deemed to be incorporated by reference in any Company filing under the Securities Act

of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such filing.

Item 8.01 Other Events.

On September 1, 2026, the Company announced

that the first patient was dosed in the global Phase 3 registrational trial of OCU410 (AAV5-hRORA), its first-in-class modifier gene

therapy candidate for Geographic Atrophy (“GA”) secondary to dry age-related macular degeneration (“dAMD”).

The initiation of dosing follows the successful completion of a Type B End-of-Phase 2 (EOP2) meeting with the Center for Biologics

Evaluation and Research (CBER) of the U.S. Food and Drug Administration (the “FDA”) in July 2026, resulting in alignment on all critical Phase 3 design elements, including primary and secondary endpoints, dose,

adaptive design, and a single pivotal trial pathway to support a Biologics License Application (BLA). In July 2026, the Company also announced that the FDA granted OCU410

Regenerative Medicine Advanced Therapy (“RMAT”) designation for the treatment of GA, secondary to dAMD.

On September 3, 2026, the independent Data Monitoring

Committee (the “DMC”) for the Phase 2/3 clinical trial of OCU410ST completed a pre-specified interim analysis and provided

its recommendation to modify and continue the clinical study as described below. This interim analysis examined atrophic lesion size in

26 subjects (16 treated and 10 control subjects) after they had completed their 8-month clinical assessments. The DMC recommended that

the study be continued per the existing protocol in order to obtain 8 months follow-up of the entire study population. The DMC noted that

one could consider futility based on the negative direction of treatment effect on the interim sample and other interim results, but the

DMC recommended the modification to obtain the entire dataset at 8 months in order to observe the results without the baseline lesion

size imbalance that existed between the treatment and control arms in the small interim analysis population and that does not exist in

the entire dataset at 8 months. The Company intends to follow the DMC’s recommendation to obtain 8 months follow-up of the entire

study population.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits.

Exhibit Number

Description

99.1

Ocugen, Inc. Presentation, September 2026.

104

Cover Page Interactive Data File (embedded within the Inline XBRL document).

Cautionary Note on Forward-Looking Statements

This Report contains forward-looking statements

within the meaning of The Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding strategy,

business plans and objectives for Ocugen’s clinical programs, plans and timelines for the preclinical and clinical development of

Ocugen’s product candidates, including the therapeutic potential, clinical benefits and safety thereof, expectations regarding timing,

success and data announcements of current ongoing preclinical and clinical trials, including the timing of enrollment and data readouts,

the ability to initiate new clinical programs, statements regarding qualitative assessments of available data, potential benefits, expectations

for ongoing clinical trials, anticipated regulatory filings and anticipated development timelines, statements regarding potential market

size and commercial possibilities of Ocugen’s product candidates, which are subject to risks and uncertainties. We may, in some

cases, use terms such as “predicts,” “believes,” “potential,” “proposed,” “continue,”

“estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,”

“could,” “might,” “will,” “should,” or other words that convey uncertainty of future events

or outcomes to identify these forward-looking statements. Such statements are subject to numerous important factors, risks, and uncertainties

that may cause actual events or results to differ materially from our current expectations, including, but not limited to, the risks that

receipt of RMAT designation may not lead to faster development or accelerated regulatory review or approval; that preliminary, interim

and top-line clinical trial results may not be indicative of, and may differ from, final clinical data; that unfavorable new clinical

trial data may emerge in ongoing clinical trials or through further analyses of existing clinical trial data; that earlier non-clinical

and clinical data and testing may not be predictive of the results or success of later clinical trials; and that clinical trial data are

subject to differing interpretations and assessments, including by regulatory authorities. These and other risks and uncertainties are

more fully described in our annual and quarterly filings with the Securities and Exchange Commission (the “SEC”), including

the risk factors described in the section entitled “Risk Factors” in the quarterly and annual reports that we file with the

SEC. Any forward-looking statements that we make in this Report speak only as of the date of this Report. Except as required by law, we

assume no obligation to update forward-looking statements contained in this Report whether as a result of new information, future events,

or otherwise, after the date of this Report.

SIGNATURE

Pursuant to the requirements

of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto

duly authorized.

OCUGEN, INC.

Date: September 8, 2026

By:

/s/ Shankar Musunuri

Name:

Shankar Musunuri

Title:

Chairman, Chief Executive Officer, & Co-Founder

EX-99.1 — EXHIBIT 99.1

EX-99.1

Filename: tm2624985d1_ex99-1.htm · Sequence: 2

Exhibit 99.1

Courageous Innovation

Dedicated to Bringing Game-Changing Gene

Therapies to Market and Working Even Harder to

Provide Access to Patients Globally

This presentation contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995,

including, but not limited to, strategy, business plans and objectives for Ocugen’s clinical programs, plans and timelines for the

preclinical and clinical development of Ocugen’s product candidates, including the therapeutic potential, clinical benefits and potential

safety thereof, expectations regarding timing, success and data announcements of current ongoing preclinical and clinical trials, the

ability to initiate new clinical programs, statements regarding qualitative assessments of available data, potential benefits, expectations

for ongoing clinical trials, anticipated regulatory filings and anticipated development timelines, which are subject to risks and

uncertainties.

We may, in some cases, use terms such as “predicts,” “believes,” “potential,” “proposed,” “continue,” “estimates,” “anticipates,”

“expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” or other words that convey uncertainty of future events or

outcomes to identify these forward-looking statements. Such statements are subject to numerous important factors, risks, and

uncertainties that may cause actual events or results to differ materially from our current expectations, including, but not limited to, the

risks that preliminary, interim and top-line clinical trial results may not be indicative of, and may differ from, final clinical data; that

unfavorable new clinical trial data may emerge in ongoing clinical trials or through further analyses of existing clinical trial data; that

earlier non-clinical and clinical data and testing of may not be predictive of the results or success of later clinical trials; and that that

clinical trial data are subject to differing interpretations and assessments, including by regulatory authorities.

These and other risks and uncertainties are more fully described in our annual and periodic filings with the Securities and Exchange

Commission (SEC), including the risk factors described in the section entitled “Risk Factors” in the quarterly and annual reports that we

file with the SEC. Any forward-looking statements that we make in this presentation speak only as of the date of this presentation.

Except as required by law, we assume no obligation to update forward-looking statements contained in this presentation whether as a

result of new information, future events, or otherwise, after the date of this presentation.

Forward Looking Statement

Ocugen – September 2026

Pioneering biotechnology company

leading the way to address major

blindness diseases with novel modifier

gene therapy

Leader in Ophthalmology

Gene Therapy

Targeting Three Biologics License Applications (BLAs) by 2028

Pipeline

Phase I Phase II Phase III Target BLA/ MAA*

Submission Program

ABCA4-associated

retinopathies caused by

1,200+ mutations

Phase 2/3 Pivotal ConfirmatoryClinical Trial in Progress

Mid 2027

100,000

(U.S. + EU)

Stargardt

Disease

OCU410ST

Designation: ODD2

, RPDD5

& OMPD3

1 Regenerative Medicine Advanced Therapy (RMAT); 2 Orphan Drug Designation (ODD); 3 Orphan Medicinal Product Designation (OMPD); 4 Advance Therapy Medicinal Products (ATMP); 5 Rare Paediatric Disease Designation (RPDD)

* Market Authorization Application will follow BLA submission

Phase 2/3 Enrollment Completed

Ocugen – September 2026

Advanced dry

age-related macular

degeneration (dAMD)

Phase 3 initiated 3Q 2026

2028

2-3 million

(U.S. + EU)

Geographic

Atrophy

OCU410

Designation: RMAT1

ATMP4

300,000

(U.S. + EU)

Gene-agnostic targeting

>100 genes, broad indication

Phase 3 in Progress (Largest Orphan Gene Therapy Clinical Trial)

2Q 2027

Retinitis

Pigmentosa

OCU400

Designations: RMAT1

, ODD2

OMPD3 & ATMP4

Phase 3 Enrollment Completed

Phase 3 Pivotal ConfirmatoryClinical Trial in Progress

Breakthrough technology designed to address many rare

diseases as well as complex diseases that affect millions

Modifier Gene Therapy Platform

Traditional therapy has limited therapeutic potential

Traditional therapy can only target

one single gene at a time, limiting

therapeutic potential.

Problem

of all human proteins are

expressed in the retina

genes are highly specialized

to it, interacting through

complex pathways

mutations affecting the

retina

have already been identified

65%

785

250+

Photoreceptor development

Inflammation and cell survival

Phototransduction

Cone cell development

Metabolism

Ocugen – September 2026

The Solution is a Gene-Agnostic Approach

Solution

Our breakthrough technology is

designed to address rare diseases

and complex diseases

Targeting

master

regulators

Master regulators control entire gene

networks. By targeting them,

Ocugen’s gene therapy platform

addresses the root cause of IRDs and

multifactorial diseases (e.g. dAMD).

Gene-Agnostic

Multifactorial

Durable Effect

Broad Impact

Ocugen – September 2026

OCU400

Retinitis Pigmentosa (RP)

Broad indication, gene-agnostic, targets 100+ genes

OCU400

First-in-Class Gene Therapy for

Retinitis Pigmentosa

Retinitis Pigmentosa (RP) is a group of rare, inherited retinal diseases

caused by mutations in over 100 genes, leading to progressive vision

loss and, in many cases, blindness.

1.6 million

2,000

Market Potential

U.S. + EU

globally suffer from RP approved treatment available

$52M peak annual sales

Luxturna® only

addresses

one gene (RPE65)

Regulatory

Milestones

(Anticipated)

One product for all 100 genes

delivered via a single,

subretinal injection

Designations

OCU400

Phase 3 trial underway —

largest orphan gene

therapy trial for RP

Enrollment completed;

Manufacturing process

validation completed;

Launch supplies ready

Topline Clinical Readout followed by

U.S. (BLA) and EU (MAA)

FDA

(RMAT + ODD)

EMA

(ATMP+ OMPD)

Patients going

untreated

298,000

Regenerative Medicine Advanced Therapy (RMAT); Orphan Drug Designation (ODD); Orphan Medicinal Product Designation (OMPD); EAP= Expanded Access Program

2026

Ocugen – September 2026

2027

OCU400

Improved Patient Visual Function and Field in Phase 1/2 Clinical Trials

*RHO +AR-NR2E3 Subjects (-Adverse Events, Sentinel); andCeiling Effect (RHO) Subjects; ceiling effect (AR-NR2E3)

#AR-NR2E3 Subjects: Baseline MLMT at 5 Lux level;1Lux level improvement resulted in ceiling effect on old scale on 0-6 Lux levels

¶ Subjects 001-003, 003-001, 001-005, 002-002 and 003-006 were responders based on the adapted LDNA Scale rounded to the nearest Lux

level. Visualfield is represented as improvements in VTOT orV30 compared to untreated eyes

63%

of Treated Eyes

Showed

Improvement

from baseline after 12

months

10s

Improvement

statistically significant

improved in MTcompletion

inTreatedEyes (p=0.031)

75%

Improvement

of VFin TreatedEyes in ITT

subgroup demonstrated

compared to untreated eyes

(6/8)

Eye Mobility Under Low Light

SubjectID(withMutation)

Mobility TestImprovement

Visual FieldImprovement

(Phase 1)

MLMTScale

LDNAScale

Patient 1

Patient 2

Patient 3

Patient 4

Patient 5

Patient 6

Patient 7

Patient 8

Ocugen – September 2026

Long-Term Durability, Safety and Tolerability Data at 3 Years

Year 1 Year 2 Year 3

OCU400demonstrated a durable improvementin visual function (LLVA)in

all evaluable treated subjects at 3Yr when compared to untreated eyes

Mean Change in LLVA (ETDRS Letters) from Baseline

Results from Phase 1/2 Study

Improvement in visual function in treated

eyes when compared to untreated eyes,

demonstrates gene-agnostic Mechanism

of Action

SevereAdverseEvents Reported

related to OCU400

88 %

treatedevaluable subjects

demonstrated improvement or

preservation in visual function

compared to untreated eyes at 3 Years

Mean ∆LLVA (

±SEM) from BL

(Treated-Untreated)

Mean ∆LLVA (

±SEM) from BL

(Treated-Untreated)

Multiple Mutations RHO

Evaluable, consented subjects for multiple mutations at Year 1 (N=11), Year 2 (N=11), Year 3 (N=8)

Evaluable, consented subjects for RHO mutations at Year 1 (N=10), Year 2 (N=8), Year 3 (N=5)

LogMar equivalent of ETDRS letters are represented for Year 3

Improvement or Preservation in evaluable Treated Eyes

Preservation = -/+4 letters from Baseline, Improvement: ≥5 Letters from Baseline

Clinically

meaningful

Clinically

meaningful

OCU400

Ocugen – September 2026

Phase 3 liMeliGhT Trial—Largest RP Data Set

OCU400

Phase 3 StudyDesign Endpoints

MTD

Determined in

Phase 1/2

Control Group

No Treatment

Treatment Group

2.5×1010 140 RP vg per eye 250 µL

patients

2:1 ratio

Visual function

improvementin

treated eye vs. control

eye

Assessed by Low-Luminance Visual Acuity

(LLVA)

Target Population

Early- to late-stage disease in broad RP population

including pediatrics (3+ years)

12-month change in

function vision

assessed by LDNA*

Improvement in Lux Level

in LDNA from baseline to

12 months

Primary Secondary

*LDNA= Luminance Dependent Navigation Assessment is a mobility test administered on a maze under different lux levels

Exploratory:

Patient Global Impression of Change (PGIC)

Top Genes Associated

with RP

Ocugen – September 2026

OCU410ST

Stargardt Disease

ABCA4 -associated retinopathies >1,200 mutations

OCU410ST

First-in-Class Gene Therapy for

Stargardt Disease

A rare IRD associated with 1,200+

mutations of the ABCA4 gene

1 million 0

Market Potential

U.S. + EU

globally suffer from ABCA4- approved treatments available

associated retinopathies

Regulatory

Milestones

(Completed/anticipated)

for upregulation of networks

of key genes improving the cell

environment and survival with

a single, subretinal injection

Designations

OCU410ST

2025

Initiated pivotal Phase 2/3

2027

Topline Data;

BLA submission

FDA

(RPDD+ ODD)

EMA

(ATMP + OMPD)

100%

of Patients going untreated

100,000

Potential Patients

2026

Enrollment completed

†

14 Ocugen – September 2026

† After completing a pre-specified interim analysis of atrophic lesion size in the Phase 2/3 clinical trial of OCU410ST in Stargardt disease, the independent Data Monitoring Committee (DMC)

recommended continuing the study according to the protocol except with a modification to obtain 8 months of follow-up on lesion size in the entire study population.

Phase 1 GARDian1 Trial Demonstrated Clinically Meaningful Benefit

OCU410ST

Lesion Size Reduction

54%

treated vs. Control

ImprovementorPreservationinevaluable TreatedEyes

Preservation = -/+4 letters from Baseline, Improvement: ≥5 Letters from Baseline NoSeriousAdverseEventsReported

N=6

*Khanani et al., Nature Eye, January 10, 2026 (https://doi.org/10.1038/s41433-025-04202-5 )

EZ Preservation

116%

Treated vs. Control

M12

-2

-1

EZ area loss (mm

) Mean (±SEM) change from BL

Treated Eye Untreated Fellow Eye

Treated Eyes

UntreatedEyes

Ocugen – September 2026

Phase 1 GARDian1 Trial Demonstrated Clinically Meaningful Benefit

Ocugen – September 2026

OCU410ST

Treated Eyes

UntreatedEyes

Visual Function*

100%

StabilizedorImproved

compared to untreated eyes

Nearly

1-line gain

In visual acuity compared to

untreated eyes

Improvement1

from Baseline

Decreasefrom

Baseline

Stabilization

N=6

*Khanani et al., Nature Eye, January 10, 2026 (https://doi.org/10.1038/s41433-025-04202-5 )

Improvement: > 5 ETDRS letters; Stabilization : ±4 ETDRS letters

Data points for M6 (N=6); M12 (N=6); *Nearly 6 Letters (Early Treatment Diabetic Retinopathy scale)

Two patients with worsening cataract (1 Low, 1 Med), 1 High dose patient with loss-to-follow upwere not included in the analysis

GARDian3- Phase 2/3 Pivotal Confirmatory Trial

OCU410ST

Trial Design Endpoints

Randomized 2:1(N=51)

DSMB

4-week Data Reviews

Functional

improvementinvision

vs. control eye

Assessed by LLVAand

BCVA

EZ analysis

(exploratory)

TargetPopulation

Early- to late-stage disease population

Including pediatrics (3+ years)

12-month change in

atrophic lesion size

from baseline vs.

control

Measured in mm2

by fundus

autofluorescence (FAF)

Treatment Group

3×1010 vg per eye in 200 µL

ControlGroup

No Treatment First Second

17 17

All

Subjects

MTD

Established in

Phase 1

Primary Secondary

DMC

Interim Outcome

Ocugen – September 2026

OCU410

Geographic Atrophy

Advanced dry age-related macular degeneration (dAMD)

OCU410

First-in-Class Gene Therapy for

GA Patients

Geographic Atrophy

Geographic Atrophy (GA) is an advanced form of dry AMD. GA causes

irreversible degeneration of retina cells in the macula, leading to loss of

central vision.

~8 million 2

Market Size

U.S. + EU

approved treatments available that

address only 1 of the 4 pathways involved

in disease progression

globally suffer from

advanced dAMD

Regulatory

Milestones

(Anticipated)

Designed to address all

four pathways associated

with GA without 6-12

injections per year and

related side effects

Designations

OCU410

3Q 2026

Initiated Phase 3

2028

Phase 3 topline data;

BLA submission

EMA (ATMP)

SYFOVRE® and IZERVAY®

>$1B combinedannual sales

2-3M

Patients

Recent Milestone

Positive 12-month Phase

2 data; first patient dosed

in Phase 3

Approved Products in US

2026

Phase 2 topline data released

2027

Complete enrollment

Ocugen – September 2026

FDA (RMAT)

1Akula et al. Gene Ther 2024; MOA= Mechanism of Action: anti-drusen activity (improves retinal function), anti-inflammatory (suppresses inflammation in HMC3 cells), anti-oxidative (improves ARPE19 cell survival), anti-complement (increases Cd59 protein)

OCU410 Aims to Disrupt GA Treatment Driven by a Novel MOA

Driving global change at the patient level

(2-3M patients in U.S. and EU )

GA Patient Experience RORA 4-way MOA1

Addresses all disease pathways – marketed therapies only

address the complement system

OCU410

Ocugen – September 2026

Endpoints

Randomization

1:1:1

EZ preservation (correlates to visualfunction)

ControlGroup

No Treatment

Primary:

Exploratory:

Medium Dose

1x 1010 vg per eye, 200 µL

High Dose

3x 1010 vg per eye, 200 µL

Phase 2 ArMaDa Trial: To Assess Safety and Efficacy of OCU410 in GA

TargetPopulation: Geographic atrophy secondary to dry AMD

• Subjects 50 years and older

• BCVA of ≥21 ETDRS Letters

• Total GA area ≥2.0 and ≤ 20.5 mm2 (1 to 8 disk areas)

• GA within foveal and nonfoveal region

• CNV in fellow eye is not exclusionary

• Subjects who had a history of pegcetacoplan or

avacincaptad pegol use were enrolled with 3M

washout period

Key Protocol Inclusion Criteria:

Change in GA lesion size measured in mm2 by FAF at Month 12

Phase 2 (ArMaDa Trial): NCT06018558

OCU410

Ocugen – September 2026

Retinal Vasculitis and/or Retinal Vascular Occlusion

Choroidal Neovascularization (CNV)

Intraocular Inflammation

Ischemic OpticNeuropathy

Treatment Emergent Serious Adverse Events

TreatmentEmergentAdverse Events

Considered Severe

OCU410

Med Dose

(N=16)

Endophthalmitis and Retinal Detachments

Adverse Events (AE), Serious AEs, Adverse Events of

Special Interest (AESI)

OCU410

High Dose

(N=16)

Control

(N=13)

# Intraocular Inflammation deemed related to study procedure – resolved

*CNV reported as AEs were not related to OCU410 based on DSMB review

No OCU410-related SAEs and AESIs reported to date

OCU410 Demonstrates Favorable Safety and Tolerability Profile

OCU410

Ocugen – September 2026

Control Medium Dose

Lesion Size Reduction

31%

treated vs control

Phase 2 Data Driving Optimal Dose for Phase 3

References for Natural History: Mones and Biarnes, 2018, TVST, N=117;

For Primary Endpoint analysis evaluable subjects include controls (N=12) and medium dose (N=16); for EZ loss analysis, Controls (N=12) and medium dose (N=13)

GA Lesion ≥2.5 mm2 and ≤17.5mm2

(Lesion criteria in prior pivotal trials supporting approval); FAF= Fundus Autofluorescence; SD-OCT= Spectral Domain Optical Coherence Tomography;

Primary analysis conducted by MMRM and p-value <0.05

Phase 3 considerations: Dose -1x1010 vg per eye; Primary Endpoint – Lesion Size Reduction; Secondary Endpoint – EZ Preservation

EZ Preservation

27%

treated vs control

0.0

0.5

1.0

1.5

2.0

2.5

GA Lesion Area (mm

) Mean (±SEM) change from BL Control Medium Dose

-31%

Ellipsoid Zone Loss (SD-OCT; N=25)

(Correlates to Visual Function)

-27%

Change in GA Lesion Area (FAF; N=28)

EZ Area loss (%)

Change from BL

p < 0.05

No disease progression in~20%

of treated subjects

75% of treated subjects

showed >30% reduction in

lesion growth

OCU410

12 Months 12 Months

Ocugen – September 2026

OCU410 Demonstrates Statistically Significant Reduction in Lesion

Size at 12 Months

OCU410 shows ~2X effect size compared to approved therapies

References: Apellis OAKS/DERBY (Heier et al, Lancet, Product Insert), IvericGATHER 2 (Liao 2023, Khanani 2024, Lancet/Ophthalmology, Product Insert), Natural History Meta-analysis (Fleckenstein 2018, Ophthalmology). Change

from Baseline for OCU410 was against ArMaDa control subjects; Dropout rates for approved therapies reported after 10 injections (PIPER|SANDLER Industry Note, June 2025);

OCU410 Optimal Dose = Medium Dose

Potentially addresses current unmet need in treating GA:

• Potential one-time treatment for life versus 6-12 injections per year

• May overcome up to 40% drop-out reported in the current standard of care

Topline, 12-month efficacy results in Phase 1 and Phase 2:

• Promising efficacy in Phase 1 and Phase 2

• Apparent structural preservation on GA lesion

• EZ preservation may support visual function

Topline data suggests favorable safety and tolerability profile:

• No SAEs and AESIs deemed related to OCU410

% Reduction in lesion size compared to

control in reported studies

1.0

1.5

2.0

2.5

Pegacetacoplan Monthly @ 24M

Pegacetacoplan EOM @ 24M

Avacincaptad pegol @ 12M

OCU410 - Optimal dose @ 12M

Control (Natural History)

-22% -19% -15%

-31%

Mean Change of GA Area (mm²) from BL

OCU410

Ocugen – September 2026

Phase 3 – Assess Efficacy, Safety and Tolerability of OCU410 in GA

Trial Design Endpoints

Randomized 2:1(N=237)

Proportion of subjects with

LLVA ≥15 Letter Loss from

Baseline to M12 as assessed

by ETDRS visual charts at

two consecutive visits

12-month change in EZ

Loss Area in study eyes vs.

control (SD-OCT)

TargetPopulation

Adults (55+years) with geographic atrophy secondary

to dry AMD (55+ years), early to late-stage disease

12-month change in GA

lesion size from baseline

vs. control

Measured in square

root mm by fundus

autofluorescence (FAF)

158

Treatment Group

1×1010 vg per eye in 200 µL

ControlGroup

No Treatment

MTD

Established in

Phase 1

Optimal Dose

established in

Phase 2

Primary Secondary

Ocugen – September 2026

Phase 3 ArMaDa Trial: NCT07770828

Ocugen Hopes to Deliver on Its Promise to Transform the

Treatment Landscape for Patients with GA

OCU410 potentially creates a new standard of care

• First-in-class RORA MOA designed to support central retina and photoreceptor integrity

• Promising Phase 2 results indicate 31% reduction in lesion size and 27% slower EZ loss

• Potential to eliminate treatment burden and patient fatigue to reduce treatment attrition

• Optimized Phase 3 trial design and targeted GA lesion size for vision preservation

• Current Global Phase 3, n=~237, >95% power, Initiated in 3Q 2026

OCU410

Ocugen – September 2026

Milestones

Anticipated Milestones – Three BLAs by 2028

Retinitis

Pigmentosa

Stargardt

Disease

Geographic

Atrophy

OCU400

OCU410ST

OCU410

100% Enrollment

Completion

Phase 3

Topline Data

Phase 2 Study Results Initiate Phase 3

2026 2027

1Q 2Q 3Q 4Q

Phase 3

ToplineData

BLA

Submission

Approval/

Launch

Approval/

Launch

BLA

Submission

1H 2H

2028

Phase 3

Enrollment Completion

1Re-estimation to minimize clinical risk (Outcome -Impact / no-impact to BLA timeline)

1Q 2Q 3Q 4Q

BLA

Submission

Ocugen – September 2026

Advancing cures for blindness

IR@ocugen.com

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